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临床试验/NCT07327086
NCT07327086已完成不适用

Evaluation of Serum Chromium, Nickel, and Magnesium Levels in Patients With Type 2 Diabetes Mellitus and Periodontitis: A Cross-Sectional Study

Kahramanmaras Sutcu Imam University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Serum levels of chromium, magnesium, and nickel

研究概览

简要总结

Periodontitis is a chronic immunoinflammatory disease that has been increasingly associated with systemic conditions, particularly type 2 diabetes mellitus (T2DM). Trace elements such as chromium (Cr), magnesium (Mg), and nickel (Ni) play important roles in metabolic regulation, insulin signaling, inflammatory responses, and tissue integrity. Alterations in the serum levels of these elements have been reported in T2DM; however, their relationship with periodontal status remains poorly understood. This cross-sectional observational study aims to evaluate serum Cr, Mg, and Ni levels in individuals with T2DM and chronic periodontitis and to investigate their potential associations with periodontal clinical parameters.

详细描述

Detailed Description

Periodontal diseases are chronic immunoinflammatory conditions initiated by the interaction between the microbial dental plaque biofilm and the host immune response, leading to progressive destruction of the alveolar bone and connective tissues. Although traditionally considered localized oral infections, increasing evidence indicates that periodontitis has significant systemic implications. A well-established bidirectional relationship exists between periodontitis and type 2 diabetes mellitus (T2DM), with periodontitis being recognized as the sixth complication of diabetes. Both conditions are characterized by elevated proinflammatory cytokines and mediators, which may mutually exacerbate disease severity and progression.

Chromium (Cr) is an essential trace element involved in carbohydrate and lipid metabolism and plays a key role in insulin signaling by enhancing insulin receptor activity through its interaction with chromodulin. Chromium deficiency has been proposed as a potential risk factor for the development of diabetes, and chromium supplementation has been reported to improve glycemic control in some individuals with T2DM. Although limited studies suggest alterations in salivary chromium levels in patients with chronic periodontitis, possibly due to periodontal tissue breakdown or metal release from restorative materials, the association between periodontal disease and serum chromium levels has not been directly investigated to date.

Magnesium (Mg) is a vital mineral acting as a cofactor for more than 300 enzymatic reactions and is essential for energy metabolism, oxidative phosphorylation, and membrane integrity. Reduced serum magnesium levels are commonly observed in individuals with T2DM, and magnesium deficiency has been associated with impaired glucose-insulin metabolism and enhanced inflammatory responses. Experimental and clinical studies suggest that magnesium deficiency may aggravate periodontal inflammation and negatively affect periodontal tissue healing; however, studies evaluating magnesium status in individuals with concomitant T2DM and chronic periodontitis are limited.

Nickel (Ni) is a widely distributed environmental heavy metal, and human exposure occurs through air, water, food, tobacco products, dental materials, and metal alloys. Evidence regarding the association between nickel exposure and diabetes is inconsistent, with some studies reporting no association and others suggesting an increased risk of diabetes with higher nickel exposure. To date, no studies have directly evaluated the relationship between periodontal disease and serum nickel levels.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged ≥18 years
  • Having at least 20 natural teeth, excluding third molars
  • Diagnosed with type 2 diabetes mellitus or systemically healthy, according to group allocation
  • Willingness to participate in the study and provision of written informed consent

排除标准

  • Presence of systemic diseases other than type 2 diabetes mellitus (e.g., renal or hepatic failure, cardiovascular disease, organ transplantation, or current or previous cancer treatment)
  • Use of antibiotics, non-steroidal anti-inflammatory drugs, corticosteroids, immunosuppressive drugs, calcium channel blockers, beta blockers, oral contraceptives, or anticoagulants within the last 3 months
  • History of non-surgical periodontal treatment within the last 6 months or periodontal surgery within the last 12 months
  • Pregnancy or lactation
  • Body mass index (BMI) ≥ 30 kg/m²
  • Current smoking or alcohol consumption
  • Use of vitamin, mineral, or antioxidant supplements within the last 3 months

研究组 & 干预措施

Control group

Systemically and periodontally healthy individuals.

干预措施: No intervention (Observational study) (Other)

Periodontitis group

Systemically healthy individuals with Stage II, Grade B periodontitis.

干预措施: No intervention (Observational study) (Other)

Controlled T2DM with periodontitis group

Individuals with HbA1c < 7.0 and Stage II, Grade B periodontitis.

干预措施: No intervention (Observational study) (Other)

Uncontrolled T2DM with periodontitis group

Individuals with HbA1c ≥ 7.0 and Stage II, Grade C periodontitis.

干预措施: No intervention (Observational study) (Other)

结局指标

主要结局

Serum levels of chromium, magnesium, and nickel

时间窗: Single time point (cross-sectional assessment)

The primary outcome is the assessment of fasting serum chromium, magnesium, and nickel concentrations measured using atomic absorption spectrometry in individuals with type 2 diabetes mellitus with and without chronic periodontitis, and systemically healthy controls.

次要结局

  • Periodontal clinical parameters(Single time point)
  • Effect of glycemic control on serum trace element levels(Single time point)
  • Association between serum trace element levels and periodontal parameters(Single time point)

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Bozkurt

Assistant Professor

Kahramanmaras Sutcu Imam University

研究点 (1)

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